FDA 510(k) Application Details - K032246

Device Classification Name Culture Media, Non-Propagating Transport

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510(K) Number K032246
Device Name Culture Media, Non-Propagating Transport
Applicant STARPLEX SCIENTIFIC, INC.
50 STEINWAY BLVD.
UNIT #5
ETOBICOKE, ONTARIO M9W 6Y3 CA
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Contact MEHDI KARAMCHI
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Regulation Number 866.2390

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Classification Product Code JSM
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Date Received 07/22/2003
Decision Date 08/13/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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